MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ESTRADIOL; RADIOIMMUNOASSAY, ESTRADIOL

Catalog Number	07K72-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect estradiol.The customer reported that they were expecting high estradiol on the architect platform, which generated lower results when compared with another analyzer platform (platform unknown).The patient doctor questioned the result based upon the treatment the patients are getting at the fertility treatment, primogyn.The customer provided the following data: sample (b)(6) result was 491.7 and result from a reference lab was 1036.40.Patient is 42-year-old female.There was no impact to patient management reported.
Additional Manufacturer Narrative
Additional information can be found in section b5.
Event or Problem Description
The customer observed falsely decreased architect estradiol.The customer reported that they were expecting high estradiol on the architect platform, which generated lower results when compared with another analyzer platform (platform unknown).The patient doctor questioned the result based upon the treatment the patients are getting at the fertility treatment, primogyn.The customer provided the following data: sample (b)(6) result was 491.7 and result from a reference lab was 1036.40.Patient is 42 year old female.There was no impact to patient management reported.The customer provided the following additional data: the customer clarified that before starting fertility treatments with primogyn the estradiol was in normal range (normal range not provided).The customer states that additional analyzer platform was the vitros instrument (amplified chemiluminescence) with unit of measure pg/ml.The customer reported that the results from the vitros were the more accurate results.
Additional Manufacturer Narrative
Additional information can be found in section b5.Correction can be found in section a2: age at time of the event.
Event or Problem Description
The customer observed falsely decreased architect estradiol.The customer reported that they were expecting high estradiol on the architect platform, which generated lower results when compared with another analyzer platform (platform unknown).The patient doctor questioned the result based upon the treatment the patients are getting at the fertility treatment, primogyn.The customer provided the following data: sample (b)(6) result was 491.7 and result from a reference lab was 1036.40.Patient is 42-year-old female.There was no impact to patient management reported.The customer provided the following additional data: the customer clarified that before starting fertility treatments with primogyn the estradiol was in normal range (normal range not provided).The customer states that additional analyzer platform was the vitros instrument (amplified chemiluminescence) with unit of measure pg/ml.The customer reported that the results from the vitros were the more accurate results.The customer provided updated information for sample (b)(6): the reference lab result for estradiol was 2290.4 pg/ml and that the patient's age is 34 years old.The customer also reported a progesterone result that was <0.5 ng/ml.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review, device history record review, and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review for the complaint lot did not identify any issues.A review of tracking and trending for the architect estradiol reagent and complaint lot did not identify an increase in complaints for the complaint issue.The overall performance of the architect estradiol reagent reviewed using field data from customers.The review of field data for the complaint lot determined the median values are within the established limits and concluded complaint lot is performing as expected.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the architect estradiol reagent lot 70229ud00.
Event or Problem Description
The customer observed falsely decreased architect estradiol.The customer reported that they were expecting high estradiol on the architect platform, which generated lower results when compared with another analyzer platform (platform unknown).The patient doctor questioned the result based upon the treatment the patients are getting at the fertility treatment, primogyn.The customer provided the following data: sample (b)(6), result was 491.7 and result from a reference lab was 1036.40.Patient is 42-year-old female.There was no impact to patient management reported.The customer provided the following additional data: the customer clarified that before starting fertility treatments with primogyn the estradiol was in normal range (normal range not provided).The customer states that additional analyzer platform was the vitros instrument (amplified chemiluminescence) with unit of measure pg/ml.The customer reported that the results from the vitros were the more accurate results.The customer provided updated information for sample (b)(6): the reference lab result for estradiol was 2290.4 pg/ml and that the patient's age is 34 years old.The customer also reported a progesterone result that was <0.5 ng/ml.

• Brand Name: ARCHITECT ESTRADIOL
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21946018
• Report Number: 3005094123-2025-00210
• Device Sequence Number: 15590466
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: (01)00380740014711(17)250830(10)70229UD00
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Catalogue Number: 07K72-25
• Device Lot Number: 70229UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 06/03/2025; 07/16/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/28/2025; 06/10/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6) ,; ARC I2000SR INST, 03M74-02, (B)(6),; ARC I2000SR INST, 03M74-02, (B)(6),; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 34 YR
• Patient Sex: Female